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1.  James Mackenzie Lecture 2013: the Tao of family medicine 
The British Journal of General Practice  2014;64(627):e675-e677.
PMCID: PMC4173733  PMID: 25267056
3.  A ‘combined framework’ approach to developing a patient decision aid: the PANDAs model 
There is a lack of practical research frameworks to guide the development of patient decision aids [PtDAs]. This paper described how a PtDA was developed using the International Patient Decision Aids (IPDAS) guideline and UK Medical Research Council (UKMRC) frameworks to support patients when making treatment decisions in type 2 diabetes mellitus.
This study used mixed methods to develop a PtDA for use in a UK general practice setting. A 10-member expert panel was convened to guide development and patients and clinicians were also interviewed individually using semi-structured interview guides to identify their decisional needs. Current literature was reviewed systematically to determine the best available evidence. The Ottawa Decision Support Framework was used to guide the presentation of the information and value clarification exercise. An iterative draft-review-revise process by the research team and review panel was conducted until the PtDA reached content and format ‘saturation’. The PtDA was then pilot-tested by users in actual consultations to assess its acceptability and feasibility. The IPDAS and UKMRC frameworks were used throughout to inform the development process.
The PANDAs PtDA was developed systematically and iteratively. Patients and clinicians highlighted the needs for information, decisional, emotional and social support, which were incorporated into the PtDA. The literature review identified gaps in high quality evidence and variations in patient outcome reporting. The PtDA comprised five components: background of the treatment options; pros and cons of each treatment option; value clarification exercise; support needs; and readiness to decide.
This study has demonstrated the feasibility of combining the IPDAS and the UKMRC frameworks for the development and evaluation of a PtDA. Future studies should test this model for developing PtDAs across different decisions and healthcare contexts.
Electronic supplementary material
The online version of this article (doi:10.1186/s12913-014-0503-7) contains supplementary material, which is available to authorized users.
PMCID: PMC4210601  PMID: 25341370
Patient decision aids; Decision making; Diabetes mellitus; Insulin; Complex intervention
4.  Predicting biopsychosocial outcomes for heroin users in primary care treatment: a prospective longitudinal cohort study 
The British Journal of General Practice  2013;63(612):e499-e505.
Opiate substitution treatment for heroin users reduces mortality, illicit drug use, crime, and risk-taking behaviour, and improves physical, mental and social functioning. Few extended studies have been carried out in UK primary care to study factors predicting recovery.
To establish whether primary care opiate substitution treatment is associated with improvements in outcomes over 11 years, in delivering recovery, and to identify predictive factors.
Design and setting
A prospective longitudinal cohort study, with repeated measures in the Primary Care Addiction Service, Sheffield, 1999–2011.
A total of 123 eligible patients were assessed using the Opiate Treatment Index at entry to treatment and at 1, 5, and 11 years. Clinical records were used to assess factors including employment and discharge status.
At 11 years, there was a high rate of drug-free discharge (22.0%) and medically-assisted recovery (30.9%), and low mortality (6.5%). Continuous treatment was associated with being discharged drug free (P = 0.005). For those still in treatment, there were highly significant reductions in heroin use and injecting, and significantly improved psychosocial functioning. There were strong positive correlations between mental health, physical health, and social functioning. Patients in employment had significantly better psychological and social functioning (P = 0.017, P = 0.007, respectively).
Opiate substitution treatment is associated over 11 years with full recovery, drug-free discharge and medically-assisted recovery. There is a strong association between the psychosocial variables, suggesting that intervention in any one of these areas may have extended benefits, by impacting on related variables and employment. The best predictor of a drug-free discharge was continuous uninterrupted treatment.
PMCID: PMC3693807  PMID: 23834887
biopsychosocial outcomes; heroin users; opiate substitution therapy; predictive factors; primary care; recovery capital
5.  Investigating active ingredients in a complex intervention: a nested study within the Patient and Decision Aids (PANDAs) randomised controlled trial for people with type 2 diabetes 
BMC Research Notes  2014;7:347.
Randomised trials provide evidence that patient decision aids improve outcomes with respect to patient knowledge, involvement and satisfaction in decision making. It is less clear how these complex interventions are implemented within patient-clinician interactions and which components are active for improving decision processes. To investigate the experiences of using a diabetes treatment decision aid and to explore how components within a complex intervention influenced the decision making process.
A pragmatic mixed methods study nested within the PANDAs cluster randomised trial of a patient decision aid. Themes inductively derived from interviews and observation of consultations with further triangulation with results of decision quality and involvement measurements and case analyses.
The decision aid intervention was employed flexibly within the consultation with both the patient and clinician active in marshalling elements. The decision aid improved processing and organization of information needed for decision making within the consultation interaction. It also improved decision quality by preparing the patient for active involvement within the clinical consultation.
The intervention was acceptable, flexible and readily implemented in primary care consultations. The decision aid was effective in facilitating cognitive processing. The intervention also facilitated rehearsal in preparation for active roles in a shared decision process.
Trial registration
Trials Register Number: ISRCTN14842077. Date registered: 24.06.2010.
PMCID: PMC4062287  PMID: 24908099
Patient decision aid; Process evaluation; Type 2 diabetes; Primary care
7.  Crystal therapy for all? 
PMCID: PMC3529297  PMID: 23336478
9.  Integration of care: a bridge too far? 
PMCID: PMC3404308  PMID: 22867654
11.  Clinical effectiveness of a patient decision aid to improve decision quality and glycaemic control in people with diabetes making treatment choices: a cluster randomised controlled trial (PANDAs) in general practice 
BMJ Open  2012;2(6):e001469.
To determine the effectiveness of a patient decision aid (PDA) to improve decision quality and glycaemic control in people with diabetes making treatment choices using a cluster randomised controlled trial (RCT).
A cluster RCT.
49 general practices in UK randomised into intervention (n=25) and control (n=24).
General practices Inclusion criteria: >4 medical partners; list size >7000; and a diabetes register with >1% of practice population. 191 practices assessed for eligibility, and 49 practices randomised and completed the study. Patients People with type 2 diabetes mellitus (T2DM) taking at least two oral glucose-lowering drugs with maximum tolerated dose with a glycosolated haemoglobin (HbA1c) greater than 7.4% (IFCC HbA1c >57 mmol/mol) or advised in the preceeding 6 months to add or consider changing to insulin therapy. Exclusion criteria: currently using insulin therapy; difficulty reading or understanding English; difficulty in understanding the purpose of the study; visual or cognitive impairment or mentally ill. A total of 182 assessed for eligibility, 175 randomised to 95 intervention and 80 controls, and 167 completion and analysis.
Brief training of clinicians and use of PDA with patients in single consultation.
Primary outcomes
Decision quality (Decisional Conflict Scores, knowledge, realistic expectations and autonomy) and glycaemic control (glycosolated haemoglobin, HbA1c).
Secondary outcomes
Knowledge and realistic expectations of the risks and benefits of insulin therapy and diabetic complications.
Intervention group: lower total Decisional Conflict Scores (17.4 vs 25.2, p<0.001); better knowledge (51.6% vs 28.8%, p<0.001); realistic expectations (risk of ‘hypo’, ‘weight gain’, ‘complications’; 81.0% vs 5.2%, 70.5% vs 5.3%, 26.3% vs 5.0% respectively, p<0.001); and were more autonomous in decision-making (64.1% vs 42.9%, p=0.012). No significant difference in the glycaemic control between the two groups.
Use of the PANDAs decision aid reduces decisional conflict, improves knowledge, promotes realistic expectations and autonomy in people with diabetes making treatment choices in general practice.
ISRCTN Trials Register Number
PMCID: PMC3532975  PMID: 23129571
Primary Care
13.  Impact of the QOF and the NICE guideline in the diagnosis andmanagement of depression: a qualitative study 
The British Journal of General Practice  2011;61(586):e279-e289.
The National Institute for Health and clinical Excellence (NICE) depression guideline (2004) and the updated Quality and Outcomes Framework (QOF) ( 2006) in general practice have introduced the concepts of screening severity assessment, for example using the Patient Health Questionnaire 9 (PHQ-9), and ‘stepped care’ for depression.
To explore primary care practitioner perspectives on the clinical utility of the NICE guideline and the impact of the QOF on diagnosis and management of depression in routine practice.
Design and setting
Qualitative study using focus groups from four multidisciplinary practice teams with diverse populations in south Yorkshire.
Four focus groups were conducted, using a topic guide and audiotaping. There were 38 participants: GPs, nurses, doctors in training, mental health workers, and a manager. Data analysis was iterative and thematic.
The NICE guideline, with its embedded principles of holism and evidence-based practice, was viewed positively but its impact was compromised by resource and practitioner barriers to implementation. The perceived imposition of the screening questions and severity assessments (PHQ-9) with no responsive training had required practitioners to work hard to minimise negative impacts on their work, for example: constantly adapting consultations to tick boxes; avoiding triggering open displays of distress without the time to offer appropriate care; positively managing how their patients were labelled. Further confusion was experienced around the evolving content of psychological interventions for depression.
Organisational barriers to the implementation of the NICE guideline and the limited scope of the QOF highlight the need for policy makers to work more effectively with the complex realities of general practice in order to systematically improve the quality and delivery of ‘managed’ care for depression.
PMCID: PMC3080233  PMID: 21619752
depression; primary health care; qualitative
14.  Delivering high-quality child health care in general practice 
PMCID: PMC3047307  PMID: 21375898
15.  Are the gates to be thrown open? 
PMCID: PMC2858526  PMID: 20423580
16.  Authors' response 
PMCID: PMC2734360
17.  Clinical research by GPs in their own practices 
PMCID: PMC2662115  PMID: 19341566
18.  Diabetes prevention 
PMCID: PMC2593542  PMID: 19068165
20.  Can type 2 diabetes be prevented in UK general practice? A lifestyle-change feasibility study (ISAIAH) 
The increasing incidence of type 2 diabetes mellitus is attributed to increasing weight, reduced physical activity, and poor diet quality. Lifestyle change in patients with pre-diabetes can reduce progression to diabetes but this is difficult to achieve in practice.
To study the effectiveness of a lifestyle-change intervention for pre-diabetes in general practice.
Design of the study
A feasibility study.
A medium-sized general practice in Sheffield.
Participants were 33 patients with pre-diabetes. The intervention was a 6-month delayed entry comparison of usual treatment with a lifestyle-change programme: increased exercise and diet change, either reduction in glycaemic load, or reduced-fat diet. The main outcome measures were weight, body mass index (BMI), waist circumference, fasting glucose, lipid profile, and nutrition.
A statistically significant difference was observed between control and intervention groups in three markers for risk of progression to diabetes (weight (P<0.03), BMI (P<0.03), and waist circumference (P<0.001)). No significant differences in fasting glucose or lipid profiles were seen. Aggregated data showed a statistically non-significant improvement in all the measures of metabolic risk of progression to diabetes in the low-glycaemic-load group when compared with a low-fat-diet group (P>0.05). Significant total energy, fat, and carbohydrate intake reduction was achieved and maintained in both groups.
A lifestyle-change intervention feasibility programme for pre-diabetic patients was implemented in general clinical practice. The potential of a low-glycaemic-load diet to be more effective than a low-fat diet in promoting change in the features associated with progression to diabetes is worthy of further investigation.
PMCID: PMC2566519  PMID: 18682012
lifestyle; motivation; prediabetic state
24.  Referral letters to colorectal surgeons: the impact of peer-mediated feedback. 
BACKGROUND: General practitioners (GPs) select few patients for specialist investigation. Having selected a patient, the GP writes a referral letter which serves primarily to convey concerns about the patient and offer background information. Referral letters to specialists sometimes provide an inadequate amount of information. The content of referral letters to colorectal surgeons can now be scored based on the views of GPs about the ideal content of referral letters. AIM: To determine if written feedback about the contents of GP referral letters mediated by local peers was acceptable to GPs and how this feedback influenced the content and variety of their referrals. DESIGN: A non-randomised control trial. SETTING: GPs in North Nottinghamshire. METHOD: In a controlled trial, 26 GPs were offered written feedback about the documented contents of their colorectal referral letters over 1 year. The feedback was designed and mediated by two nominated local GPs. The contents of referral letters were measured in the year before and 6 months after feedback. GPs were asked about the style of the feedback. The contents of referral letters and the proportion of patients with organic pathology were compared for the feedback GPs and other local GPs who could be identified as having used the same hospital for their referrals in the period before and after feedback. RESULTS: All GPs declared the method of feedback to be acceptable but raised concerns about their own performance, and some were upset by the experience. None withdrew from the project. There was a difference of 7.1 points (95% confidence interval = 1.9 to 12.2) in the content scores between the feedback group and the controls after adjusting for baseline differences between the groups. Of the GPs who referred to the same hospital before and after feedback, the feedback GPs referred more patients with organic pathology than other local colleagues. CONCLUSIONS: GPs welcome feedback about the details appearing on their referral letters, although peer comparisons may not always lead to changes in practice. However, in some cases feedback improves the content of GP referral letters and may also impact on the type of patients referred for investigation by specialists.
PMCID: PMC1314806  PMID: 14965392
25.  Psychological treatment for insomnia in the management of long-term hypnotic drug use: a pragmatic randomised controlled trial. 
OBJECTIVE: To evaluate the clinical and cost impact of providing cognitive behaviour therapy (CBT) for insomnia (comprising sleep hygiene, stimulus control, relaxation and cognitive therapy components) to long-term hypnotic drug users in general practice. DESIGN: A pragmatic randomised controlled trial with two treatment arms (a CBT treated 'sleep clinic' group, and a 'no additional treatment' control group), with post-treatment assessments commencing at 3 and 6 months. SETTING: Twenty-three general practices in Sheffield, UK. PARTICIPANTS: Two hundred and nine serially referred patients aged 31-92 years with chronic sleep problems who had been using hypnotic drugs for at least 1 month (mean duration = 13.4 years). RESULTS: At 3- and 6-month follow-ups patients treated with CBT reported significant reductions in sleep latency, significant improvements in sleep efficiency, and significant reductions in the frequency of hypnotic drug use (all P<0.01). Among CBT treated patients SF-36 scores showed significant improvements in vitality at 3 months (P<0.01). Older age presented no barrier to successful treatment outcomes. The total cost of service provision was 154.40 per patient, with a mean incremental cost per quality-adjusted life-year of 3416 (at 6 months). However, there was evidence of longer term cost offsets owing to reductions in sleeping tablet use and reduced utilisation of primary care services. CONCLUSIONS: In routine general practice settings, psychological treatments for insomnia can improve sleep quality and reduce hypnotic consumption at a favourable cost among long-term hypnotic users with chronic sleep difficulties.
PMCID: PMC1314744  PMID: 14960215

Results 1-25 (34)